Dr. Scott Gottlieb told CNBC on Monday he expects U.S. drug regulators to clear the Pfizer-BioNTech Covid-19 vaccine for emergency use in children ages 5 to 11 in late fall or early winter this year.
The Pfizer board member said data from the
company’s vaccine trials for kids in that age group “should be available in September,” and then submitted to the Food and Drug Administration that month.
“The application probably isn’t going to be submitted until some point in October,” said
Gottlieb, who led the FDA from 2017 to 2019 during the Trump administration.
“If the FDA sticks to its normal timeline, in terms of how it reviews these applications, you would expect that review to be a four-to-six week review for a potentially
emergency use authorization, so that puts you on a timeline where you’re late fall, early winter,” Gottlieb added in a “Squawk Box” interview.
Gottlieb’s expectations are in line with recent remarks from White House chief medical advisor Dr.
Anthony Fauci on NBC’s “Today” show.
The Pfizer-BioNTech two-shot Covid vaccine is currently the only one to receive full FDA approval, which happened Aug. 23. However, that designation is only for people ages 16 and up. Kids ages 12 to 15
are still able to get Pfizer but on an emergency use basis.
The single Johnson & Johnson shot and the two-dose Moderna vaccine, both under emergency use in the U.S., are cleared for those 18 and up. Moderna has applied for full FDA approval
for that age range. J&J has not sought any type of full approval yet. Back in June, Moderna applied to expand its emergency use authorization to cover kids ages 12 to 17.
Young children having the ability to be vaccinated is an important step
in combating the pandemic in the U.S., particularly as kids return to school for the fall. Last week, pediatric Covid hospitalizations reached their highest level on record since U.S. health officials started recording them about a year ago. While the
coronavirus poses lower risk to children than people older than 65, for example, some studies suggest that kids who get infected can still pass the virus on to other people.
Print Page
Email to a Friend